Pregnant women with epilepsy often must take an anti-seizure drug like Neurontin. Unfortunately, many women are not aware of the birth defect risk associated with these medications.
What is Neurontin?
Neurontin (gabapentin) is a prescription medication used to treat certain types of seizures. It is also used to treat Restless Legs Syndrome (RLS) and painful nerve damage caused by shingles. Neurontin is made by Pfizer and was approved by the FDA in December 1993.
In recent years, a number of women have filed lawsuits after they used Neurontin during pregnancy and had a baby with a birth defect. Our lawyers are investigating potential lawsuits involving the following birth defects:
- Cleft lip
- Cleft palate
- Heart defects
- Spina bifida
- Limb reduction defects
- Gastrointestinal defects
- Reproductive system defects (hypospadia)
- And more
Neurontin and Pregnancy
Neurontin is a Pregnancy Category C medication. This means the FDA does not recommend Neurontin during pregnancy because there are no adequate or well-controlled studies in pregnant women.
In studies of pregnant mice, Neurontin caused skeletal birth defects. Other studies in animals showed that Neurontin was “developmentally toxic” during pregnancy at doses equivalent or lower than what a person would use.
Anti-Seizure Drugs Linked to Birth Defects
Pregnant women with epilepsy walk a fine line between controlling seizures and reducing the risk to their developing baby. Epileptic seizures can harm a fetus, which is why many pregnant women take anti-seizure medications. Unfortunately, all of these medications carry some risk of birth defects.
Some anti-seizure medications have higher risks than others. Several studies have concluded that Neurontin does not increase the risk of birth defects, or at least has a lower risk of birth defects than Topamax.
The anti-seizure drug Topamax (topiramate) has been linked to a 20-fold increased risk of cleft lip and cleft palate. Another anti-seizure drug, Depakote (valproate), has been linked to neural tube defects, heart defects, and craniofacial defects. Both of these drugs are “Pregnancy Category D.”
Neurontin Marketed “Off-Label”
On May 13, 2004, the Justice Department announced a $430 million settlement with the manufacturer of Neurontin. The drug-maker was accuse of aggressively promoting Neurontin for “off-label” purposes that were not approved by the FDA, including:
- Bipolar mental disorder
- Various pain disorders
- Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig’s Disease)
- Attention deficit disorder
- Drug and alcohol withdrawal seizures
- Restless leg syndrome
- As a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug).
Neurontin Class Action
The Clark Firm, LLP is nationally recognized as a class action law firm. However, instead of a Neurontin class action, our attorneys are filing individual lawsuits so we can focus on seeking justice and maximizing compensation for people with the most serious injuries.